4 ms·
Agreed on the conflation, and clearly there are many parts of the FDA that need attention. However this article is misleading because it focuses heavily on one
by entee 6y ago
Agreed on the conflation, and clearly there are many parts of the FDA that need attention. However this article is misleading because it focuses heavily on one teams (basically then Seattle Flu Study) of extremely competent people hamstrung by onerous requirements. It ignores the many more incompetent people stopped by more scrutiny and the errors that low scrutiny produce.
As an example for the latter I point to antibody tests, many of which were given approval despite being poorly validated (1). These cause at least as much harm as good.
The FDA needs to improve and we need to remove some counterproductive regulatory steps (when the emergency was declared, in some ways it got harder to approve a test under EUA, that should be adjusted). But lets remember that hasty decisions in medicine can cost lives (see thalidomide, which the FDA mostly dodged unlike Europe, or Viox). We shouldn’t make broad decisions on examples cherry picked from the best case scenarios.
1.) https://khn.org/news/antibody-tests-were-hailed-as-way-to-end-lockdowns-instead-they-cause-confusion/ https://khn.org/news/antibody-tests-were-hailed-as-way-to-en...